The following is not intended to represent an all-inclusive list of job responsibilities, but to outline the ESSENTIAL FUNCTIONS of the position.
The Sr. Manager, Quality Assurance:
Ensures that the products and processes meet or exceed both external and internal specific requirements, including customer expectations, throughout all phases of the product life cycle.
Monitors and advices on the performance of the products and the manufacturing processes, including outsourced and in-sourced operations, and oversees the quality indicators and report on performance against set goals.
Liaises with other Business and Functional Managers and Staff throughout the organization, to ensure that the quality assurance activities are being properly planned, implemented, executed, and maintained.
Oversees the Quality Assurance group, including Quality Engineering, and Quality Control.
Fully comply with all quality standards and requirements related to Medical Devices.
Stop further processing of a product in the event of encountering nonconformities.
Identify any product risk and escalate as required.
Collaborate with other Departments to achieve business objectives and goals.
Agree on standards and establish clearly defined quality methods for staff to apply.
Support the development, modification, and execution of quality guidelines and procedures.
Assist in SOP development, review and implementation.
Identify relevant quality-related training needs and deliver training as required.
Participate and assist in the Internal Audit and during external quality system and regulatory inspections.
Ensure tests and procedures are properly understood, carried out and evaluated and that product nonconformities are investigated if necessary.
Lead and support product failure analysis, including root cause analysis, and identification of corrective actions and preventive actions.
Review and approve test reports showing product conforms to pre-established requirements.
Provide quality input to new product development, manufacturing deviations, and design and process changes.
Work with purchasing staff to establish quality requirements for external suppliers.
Coordinate with Supply Chain and Purchasing in regards to raw material suitability and change control affecting critical-to-quality attributes of the product.
Where appropriate, advice on changes and their implementation and provide training, tools and techniques to enable others to achieve quality.
Maintain accurate and efficient written and verbal communication with corporate customers and provide updates on major or recurring quality issues.
Set quality objectives and ensure that targets are achieved;
Lead the business quality managers, supervisors and engineers to understand the product specifications of the company and its suppliers, and ensure the product comply with customer requirements;
Monitor product and processes performance by reviewing relevant data and analyzing statistical reports.
Promote quality achievement and the Quality Culture throughout the organization.
Drive quality improvement efforts to reduce customer complaints and manufacturing defects affecting the business objectives.
Change Control Product Quality Advisor
Member of the Change Control Board.
Review and approve design and process changes and assess their impact on product quality.
Oversees the Quality Control activities, ensuring adequate inspection and tests are been carried out and containment activities immediately as required.
Directly supervise the business and supplier quality managers or supervisors.
Supervise through subordinate managers and/or supervisors the activities of the Quality Engineering, Quality Control teams and other areas as assigned.
Set overall QA group objectives, key metrics and goals.
Establish priorities and align strategies and projects to the Corporate, Business, Department, and QA group objectives.
Evaluate subordinates' performance against those goals and priorities.
Perform Staffing reviews of subordinates and oversee the staffing of the QA group.
Coach and develop direct report subordinates.
Follow-up and ensure personnel training records are up-to-date and in compliance with requirements.
Maintain awareness of the business context and company profitability, including budgetary control issues.
Responsible for compliance with company human resources policies.
Amount of force frequently or constantly to lift, carry, etc. generally involves sitting most of the time.
Must be able to communicate with large groups of people
Literacy (read, write).
Able to travel up to 30%.
Must be able to generate and explain detailed proposals, guidelines, and procedures to departmental and/or non-departmental personnel.
Must be able to analyze and resolve non-routine product issues using independent judgment.
Ability to independently identify product risks and escalate as necessary.
Must be able to routinely make decisions which may affect immediate business operations and have a company-wide effect.
Must be able to understand general financial principal and to prepare and maintain a departmental budget for the assigned areas.
Must be able to observe and correct minute inconsistencies (e.g. in the printed word, a production process, product appearance, etc.)
Fully bilingual (Spanish, English)
Excellent reading and writing skills
Excellent oral communication skills
Excellent analytical skills (Problem Solving, Critical thinking)
Excellent interpersonal skills (relationships, influence, negotiation, teamwork)
Demonstrated effective managerial skills
Excellent organizational skills
10+ years of overall experience in a regulated industry Medical Devices, Pharmaceutical or equivalent
6 to 8 years of experience in Quality and Regulatory Compliance function or equivalent experience.
At least 4 years of experience in Management position in Quality Assurance or equivalent position.
Required Education and Training:
B.S. in Science, Engineering, Engineering management, or related discipline
Master degree in Engineering or related discipline is a plus.
Formal training in FDA regulatory quality system regulations (21 CFR 820) and applicable International Standards (ISO 13845) or equivalent education.
Formal education or training on Quality Management tools and/or Continuous improvement methodologies, including TQM, Six Sigma, Lean Manufacturing, etc.
Professional Certification is highly desirable (American Society of Quality, Association for the Advancement of Medical Instrumentation, etc).
Work From Home: No
Travel Percentage: Up to 25%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.